BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13791704 · Received March 17, 2022

    Report

    Report Number
    8010047-2022-04540
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    October 5, 2020
    Report Date
    July 5, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K954451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AVERAGE AGE/YEARS FOR PATIENTS WAS 73.5 FOR CONVENTIONAL ESD GROUP. AVERAGE AGE/YEARS FOR PATIENTS WAS 74.2 FOR MULTIBENDING ESD GROUP. GENDER: MALE (21) AND FEMALE (9) FOR CONVENTIONAL ESD GROUP. GENDER: MALE (19) AND FEMALE (11) FOR MULTIBENDING ESD GROUP. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    CORRECTION: D4. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION AND DEVICE HISTORY RECORD (DHR) REVIEW AND APPLICABLE CORRECTION. NEW INFORMATION WAS ADDED TO THE FOLLOWING FIELDS: D8, H4, H6, AND H10. THE DHR FOR THIS DEVICE WAS REVIEWED AND ALL RECORDS INDICATED THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR. D10: THE CV-290 USED IN THE PROCEDURE MAY HAVE BEEN ONE OR MORE OF THE FOLLOWING SERIAL NUMBERS: (B)(6).

    Description of Event or Problem · 0

    OLYMPUS RECEIVED THE FOLLOWING LITERATURE ARTICLE: CLINICAL BENEFIT OF THE MULTIBENDING ENDOSCOPE FOR GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION: A RANDOMIZED CONTROLLED TRIAL BY K. HAMADA, ET AL. THE STUDY EVALUATED THE SAFETY AND EFFICACY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING A MULTIBENDING ENDOSCOPE IN THE TREATMENT OF SUPERFICIAL GASTROINTESTINAL NEOPLASMS. A TOTAL OF 60 PATIENTS WERE RANDOMIZED (1:1) TO RECEIVE CONVENTIONAL ESD (C-ESD) OR MULTIBENDING ESD (M-ESD), WITH NO FOLLOW-UP ENDOSCOPY. PATIENTS WERE PERMITTED TO BE DISCHARGED ON THE FOURTH POSTOPERATIVE DAY AND HAD A POSTOPERATIVE CONSULTATION 2 WEEKS AND 6 MONTHS AFTER DISCHARGE. THE EVALUATION WAS CONDUCTED FOR ESD PROCEDURE TIME, THE PRIMARY OUTCOME, AND THE DISSECTION SPEED, PERI-OPERATIVE COMPLICATIONS, INTRAOPERATIVE PERFORATION, DELAYED BLEEDING, DELAYED PERFORATION, AND DAMAGE TO THE MUSCLE LAYERS DURING ESD WERE AMONG THE SECONDARY OUTCOMES. THE REPORTED MEDIAN ESD PROCEDURE TIME WAS 36.0 MINUTES, WITH A SIGNIFICANTLY SHORTER PROCEDURE TIME NOTICED IN THE M-ESD GROUP. THE MEAN DISSECTION SPEED WAS SIGNIFICANTLY FASTER IN THE M-ESD GROUP THAN IN THE C-ESD GROUP. ALSO, MUSCLE LAYER DAMAGE OCCURRED SIGNIFICANTLY LESS FREQUENTLY IN THE M-ESD GROUP. IN CONCLUSION, THE STUDY FAVORED M-ESD AND SAID A SHORTER PROCEDURE TIME COULD DECREASE NOT ONLY THE RISK OF COMPLICATIONS BUT ALSO THE COST AND BURDEN ON THE MEDICAL STAFF. IN THE C-ESD GROUP, A GIF-Q260J EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE WITH A WATERJET SYSTEM AND A KD-655L SINGLE USE ELECTROSURGICAL KNIFE/ DUALKNIFE J WERE USED. MUSCLE LAYER DAMAGE WAS DEFINED AS FINDINGS IN WHICH THE CIRCULAR MUSCLE WAS DAMAGED BY ENERGIZATION OF THE ELECTRICAL KNIFE. COMPLICATIONS OCCURRED SUCH AS MUSCLE LAYER DAMAGE. IN THE M-ESD GROUP, A GIF-2TQ260M EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE AND A KD-655L SINGLE USE ELECTROSURGICAL KNIFE/ DUALKNIFE J WERE USED. COMPLICATIONS OCCURRED SUCH AS DELAYED BLEEDING AND MUSCLE LAYER DAMAGE. THE ADVERSE EVENTS REPORTED IN THE STUDY: MUSCLE LAYER DAMAGE (1). THIS EVENT INCLUDES THREE (3) REPORTS: (B)(6) FOR GIF-2TQ260M: DELAYED BLEEDING (2) AND MUSCLE LAYER DAMAGE (1). (B)(6) FOR GIF-Q260J: MUSCLE LAYER DAMAGE (1). (B)(6) FOR KD-655L: DELAYED BLEEDING (2) AND MUSCLE LAYER DAMAGE (2). THIS IS REPORT 2 OF 3 FOR (B)(6) FOR GIF-Q260J.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR. THE ADVERSE EVENT WAS NOT RELATED TO THE OLYMPUS DEVICES OR THE UNDERLYING CONDITION(S) OF THE PATIENT. THERE WERE NO MALFUNCTIONS OF OLYMPUS DEVICES IN THE STUDY. THE TREATMENTS PROVIDED TO THE PATIENTS WITH ADVERSE EVENTS WERE NOT PROVIDED TO OLYMPUS. THE EVIS LUCERA ELITE VIDEO SYSTEM CENTER, CV-290 WAS ALSO USED IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246259 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-Q260J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other EVIS LUCERA ELITE VIDEO SYSTEM CENTER, CV-290.| KD-655L, DUALKNIFE J.| VIO 300 D, ELECTROSURGICAL UNIT, ERBE.